N/A
N=3,130
Evaluation of Effectiveness of the Treatment After Repeated Administration of Klacid®SR
Tracheitis · Tracheobronchitis · Bronchitis · Chronic Bronchitis · Community-Acquired Pneumonia (CAP)
Bottom Line
View on ClinicalTrials.gov: NCT01130883 ↗Enrolled (actual)
3,130
Serious AEs
0.1%
Results posted
Aug 2011
Primary outcome: Primary: Disappearance or Significant Alleviation of Symptoms — 3109 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Disappearance or Significant Alleviation of Symptoms |
3109 | — |
| PRIMARY Change in Auscultation Findings, Regression of Chest X-ray Findings (Recorded by the Physician) |
956; 2146; 26; 2768; 247; 113 | — |
| SECONDARY Body Temperature |
2252; 870; 6; 101; 3013; 14 | — |
| SECONDARY Bacteriological Investigation (if Available) |
48; 38; 34; 14; 13; 12 | — |
| SECONDARY Cough and Its Character |
2942; 1601; 1177; 157; 7; 186 | — |
| SECONDARY Dyspnea and Its Type |
1091; 794; 235; 60; 2; 2037 | — |
| SECONDARY Auscultation |
2146; 1577; 408; 145; 16; 247 | — |
| SECONDARY Chest X-ray in Case of Community-Acquired Pneumonia (CAP) |
276; 18 | — |
| SECONDARY Study Drug Given as the First, Second or Third Antimicrobial Treatment |
2910; 216; 2 | — |
| SECONDARY Compliance |
3122 | — |
| SECONDARY Termination of Treatment Due to Noncompliance |
6 | — |
Summary
This post-marketing observational study (PMOS) will be conducted in a prospective, single-arm, single-country, multicenter format. The investigational sites will be consulting rooms of GPs (general practitioner), pneumologists and centers with experience in the treatment of patients with acute infections of trachea, bronchi, AECB (acute exacerbation of chronic bronchitis) and CAP (mild community-acquired pneumonia). Since this will be a post-marketing observational study, Klacid SR will be prescribed in usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. Objective: to describe the effectiveness of the treatment with repeated administration of Klacid SR in patients with acute tracheitis, acute tracheobronchitis or acute bronchitis; or in patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose administered within this study.
Eligibility Criteria
Inclusion Criteria
- Men, women at least 18 years old.
- Patients treated with Klacid®SR between 6 weeks and 24 months prior to start of the PMOS.
- Patients:
- with acute tracheitis,
- acute tracheobronchitis,
- acute bronchitis,
- mild community-acquired pneumonia or
- acute exacerbation of chronic bronchitis
Exclusion Criteria
- Patients without previous administration of Klacid®SR and patients who used Klacid®SR less than 6 weeks ago or more than 24 months ago. The information about previous administration of Klacid®SR will be based on physician records or patients anamnesis.
- Patients with known hypersensitivity to macrolide antibiotics
- Patients with documented renal impairment (creatinine clearance under 30 ml/min).
- Patients with documented liver parenchyma impairment (AST, ALT and GMT > 3x higher level in comparison with the norm)
- Concomitant therapy with the following drugs: astemizole, cisapride, colchicine, pimozide, terfenadine and ergotamine or dihydroergotamine
- Pregnancy
- Breast feeding
Data sourced from ClinicalTrials.gov (NCT01130883). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.